PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)
17 maj 2019 uppdaterad av: Medtronic - MITG
PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)
PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort.
The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
1495
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Suresnes, Frankrike, 92151
- Hospital Foch
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University Of Colorado Hospital
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital
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Michigan
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Royal Oak, Michigan, Förenta staterna, 48073
- Beaumont Hospital - Royal Oak
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New York
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Buffalo, New York, Förenta staterna, 14203
- Buffalo General Medical Center
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
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Cleveland, Ohio, Förenta staterna, 44109
- MetroHealth Medical Center
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Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University Wexner Medical Center
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Washington
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Everett, Washington, Förenta staterna, 98201-1689
- Providence Regional Medical Center Everett
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Tokyo, Japan, 105-8471
- The Jikei University School of Medicine Hospital
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Limburg
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Maastricht, Limburg, Nederländerna, 6229 HX
- Maastricht UMC+
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Singapore, Singapore, 119074
- National University Hospital
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Valencia, Spanien, 46010
- Hospital Clínico Universitario de Valencia
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Bonn, Tyskland, 53127
- University Hospital Bonn
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients receiving parenteral opioid therapy (for post-surgical or non-surgical) pain on the hospital ward.
- Adult age (≥18 year old in US and Europe; ≥20 years old in Japan; ≥21 years old in Singapore).
- Patient is able and willing to give informed consent.
Exclusion Criteria:
- Expected length of stay ≤ 24 hours.
- Patient is receiving intrathecal opioids.
- Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
- Patients with the status of Do Not Resuscitate (DNR), hospice, or receiving end of life therapy.
- Ventilated or intubated patients.
- Patient is unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome.
- Patient is a member of a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support.
- Patient is participating in another potentially confounding drug or device clinical study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Övrig: Patients monitored by capnography
Capnography and pulse oximetry monitoring data will be collected for up to 48 hours while patients are on the hospital ward.
In addition, a 1-month follow up will be completed.
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Capnography and pulse oximetry monitoring data will be collected for up to 48 hours while patients are on the hospital ward.
In addition, a 1-month follow up will be completed.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Determine Number of Subjects With RD While on Opioid Therapy
Tidsram: 48 hours
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Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2). Positive RD determination was provided by an independent Clinical Event Committee, by assessing the following parameters:
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48 hours
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To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward
Tidsram: 48 hours
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A risk assessment tool will be derived and validated using the incidence of RD episodes captured by continuous capnography and pulse oximetry measurements recorded on the Capnostream device memory data in conjunction with the clinical data as reported by the investigator.
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48 hours
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Frank J Overdyk, Roper St. Francis Healthcare
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.
- Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008.
- Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8. doi: 10.1213/01.ane.0000269489.26048.63.
- Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. doi: 10.1093/bja/aeh180. Epub 2004 May 28.
- Kor JJ, Sprung J, Khanna AK, Weingarten TN. Continuous Monitoring Detected Respiratory Depressive Episodes in Proximity to Adverse Respiratory Events During the PRODIGY Trial. J Patient Saf. 2022 Dec 1;18(8):738-741. doi: 10.1097/PTS.0000000000001003. Epub 2022 Apr 27.
- Sim MA, Seet E, Khanna AK, Weingarten TN, Liew L, Law LS, Liu KE, Di Piazza F, Ti LK; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Association Between Race and Opioid-Induced Respiratory Depression: An International Post Hoc Analysis of the Prediction of Opioid-induced Respiratory Depression In Patients Monitored by Capnography Trial. Anesth Analg. 2022 Nov 1;135(5):1097-1105. doi: 10.1213/ANE.0000000000006006. Epub 2022 Mar 29.
- Khanna AK, Jungquist CR, Buhre W, Soto R, Di Piazza F, Saager L; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Modeling the Cost Savings of Continuous Pulse Oximetry and Capnography Monitoring of United States General Care Floor Patients Receiving Opioids Based on the PRODIGY Trial. Adv Ther. 2021 Jul;38(7):3745-3759. doi: 10.1007/s12325-021-01779-7. Epub 2021 May 24.
- Khanna AK, Saager L, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Ti LK, Soto R, Jiang W, Buhre W. Opioid-induced respiratory depression increases hospital costs and length of stay in patients recovering on the general care floor. BMC Anesthesiol. 2021 Mar 20;21(1):88. doi: 10.1186/s12871-021-01307-8.
- Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22.
- Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
- Khanna AK, Overdyk FJ, Greening C, Di Stefano P, Buhre WF. Respiratory depression in low acuity hospital settings-Seeking answers from the PRODIGY trial. J Crit Care. 2018 Oct;47:80-87. doi: 10.1016/j.jcrc.2018.06.014. Epub 2018 Jun 18.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
7 april 2017
Primärt slutförande (Faktisk)
7 maj 2018
Avslutad studie (Faktisk)
7 maj 2018
Studieregistreringsdatum
Först inskickad
21 juni 2016
Först inskickad som uppfyllde QC-kriterierna
21 juni 2016
Första postat (Uppskatta)
23 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- COVMOPO0560
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